Dupilumab Meaningfully Reduces Symptoms for Patients With EoE, Study Finds

Parts A and C of the LIBERTY-EoE-TREET study found weekly dupilumab resulted in statistically significant and meaningful symptom improvements in adults and adolescents with eosinophilic esophagitis (EoE) compared with patients on placebo, according to an abstract presented at the 2022 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

The abstracts presented findings from 3 parts of the study. One abstract reviewed results from Part A and Part C.¹ Part A was a 24-week study comparing dupilumab 300 mg vs placebo and Part C was a 28-week extended active treatment period for patients who completed Part A. Part C evaluated the safety and efficacy of dupilumab 300 mg for a total of 52 weeks.

A total of 81 patients were enrolled in Part A: 42 patients on dupilumab and 39 patients on placebo. After Part A, 77 patients continued on to receive dupilumab in Part C: 40 of the patients had been on dupilumab in Part A and continued on dupilumab in Part C and 37 patients had been on placebo in Part A and continued on dupilumab in Part C.

In Part A, baseline biomarker levels were similar across the 2 groups and at the end of 24 weeks the median changes from baseline were:

• Serum thymus and activation-regulated chemokine (TARC): −115.5 (−204.0 to −60.0) pg/mL for patients on dupilumab vs −35.0 (−67.0 to 32.0) pg/mL for patients on placebo
• Eotaxin-3: −88.6 (−212.0 to −47.0) pg/mL on dupilumab vs −9.0 (−148.0 to 53.0) pg/mL on placebo
• Serum total immunoglobulin E (IgE): −45.7 (−198.0 to −23.7) kU/L for dupilumab vs −8.6 (−72.0 to 4.7) kU/L for placebo

In Part C, serum TARC, eotaxin-3, and serum total IgE continued to decline to a lesser degree for the dupilumab/dupilumab patients. The patients who were on placebo/dupilumab also reported significant changes with median declines from baseline of:

1. TARC: −122.0 (−194.0 to −28.0) pg/mL
2. Eotaxin-3: −160.9 (−367.0 to −104.6) pg/mL
3. Serum total IgE: −57.6 (−178.8 to −28.7) kU/L

The safety evaluation in Part C found that injection-site reactions occurred in 10.0% of dupilumab/dupilumab patients and 21.6% of placebo/dupilumab patients and injection-site erythema occurred in 10.0% of dupilumab/dupilumab patients and 13.5% of placebo/dupilumab patients.

Part B of the study, which included 159 patients randomized to dupilumab (n = 80) or placebo (n = 79), was also presented at the AAAAI meeting.

In the abstract reporting on results from Part B, the authors noted that the findings from the arm replicated the results from Part A of the LIBERTY-EoE-TREET study.²

“Weekly dupilumab vs placebo demonstrated statistically significant, clinically meaningful improvements in symptoms in adults/adolescents with EoE, with a greater proportion of patients achieving histological remission,” the authors concluded.

References

1. Hirano I, Dellon E, Collins M, et al. Dupilumab reduces biomarkers of type 2 inflammation in adult and adolescent patients with eosinophilic esophagitis: results from Parts A and C of a three-part, phase 3 LIBERTY EoE TREET study. Presented at: AAAAI 2022 Annual Meeting; February 25-28, 2022; Phoenix, Arizona. Abstract 633.

2. Dellon E, Bredenoord A, Collins M, et al. Dupilumab improves clinical and histologic aspects of disease in adult and adolescent patients with eosinophilic esophagitis at week 24: results from Part B of the 3-part LIBERTY EoE TREET study. Presented at: AAAAI 2022 Annual Meeting; February 25-28, 2022; Phoenix, Arizona. Abstract L02.